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Cancer treatment Related Mucositis usually occurs within two weeks of initiation of many chemotherapy and radiation regimens. Mucositis can lead to dysphagia (painful swallowing), weight-loss, infection, and sepsis (from bacteria such as E.coli which leak from the intestine). It is a leading cause of discontinuation of chemotherapy treatment. Radiation therapy is also a recognized cause of mucosal damage leading to the inflammation and ulceration from Mucositis.

The Anadis Mucositis program benefits tremendously from the know-how incorporated in the Anadis E.coli prevention product, Travelan, and from over a decade of extensive research in the Gastro-Intestinal field. A product is expected to reach the market in 3 years.

The global Mucositis market is large and there is currently no dominant or broadly effective treatment for either Oral Mucositis or Gastro-Intestinal Mucositis. In the USA more than 1 million patients undergo chemotherapy annually, receiving an average of four months’ treatment each. More than 1 million patients undergo radiation treatments annually for an average of two months each, including time to resolve gastro-intestinal side-effects.

Prevalence of Mucositis varies across treatments, ranging from a low of 12% in patients receiving adjuvant chemotherapy to 99% in patients receiving bone marrow transplant. Other estimates indicate a range of more than 50% in patients on high-dose chemotherapy or those with leukemia, 21%-31% in patients with solid tumors, and 60%-90% in patients with head and neck cancer receiving standard chemotherapy and radiation therapy.

The market outside the USA is estimated to be at least as large, with similar Mucositis rates. There are only a few solutions for these severe problems, with one of the main solutions being a recently released drug (approved for only limited indications) priced at $6,000-$8,000 per regimen.

The Anadis product for Mucositis is expected to offer broad applicability and is planned to be marketed by prescription only as a medical food, a category that allows for high reimbursement rates. As defined by the U.S. FDA, a medical food is prescribed by a physician when a patient has special nutrient needs in order to manage a disease or health condition, and the patient is under the physician's ongoing care. The special formulation is developed and harvested using the proprietary Anadis HIDDA platform (Hyper Immunized Dairy Derived Antibodies).

Anadis’ clinical studies (anadis.com) will be undertaken at several major cancer centers in Israel, led by cancer specialists at the Sheba Medical Center and the Sourasky Medical Center, both in Tel Aviv, Israel. The study will be completed during 2008.

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